Gynaecological Malignant Tumours With Indication of Pelvic LymphadenectomyPhase 4SENTIJAMBENCT01946672
Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer
A Phase 4 study testing Lower-limb drainage isotopic intraoperative detection in people with Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy
- What is being tested?
- Lower-limb drainage isotopic intraoperative detection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to 4 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:
- High risk endometrial cancer (stage IB type I grade 3, stage I type II, stage> IB) or with metastatic sentinel lymph node,
- Early cervical cancer, or with metastatic sentinel lymph node,
- Ovarian cancer.
- Must provide her signed and informed consent
- Beneficiary of a health insurance
- Having received a medical examination
Who cannot join
- Contraindication to pelvic lymphadenectomy
- Presence of lymphedema of the lower limbs
- Contraindication to radiomarkers (allergy or hypersensitivity to any component of the biomarker)
- Patient with dementia or altered mental status
- Pregnant or breast feeding patients
- Participation in any other clinical trial that could interfere with the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.
Read the detailed description
Pelvic lymphadenectomy is associated with a significant risk of lower-limb lymphedema. In this study, we evaluate the feasibility of identifying the lower-limb drainage nodes (LLDNs) during pelvic lymphadenectomy for gynaecological cancers using an isotopic detection technique with a preoperative radiopharmaceutical injection into both feet Secondary objectives are to map lower-limb drainage, to assess the diagnostic value of our mapping technique, and to determine the incidence of lymphedema. LLDN mapping may allow the preservation of LLDNs, thereby decreasing the risk of lower-limb lymphedema and improving quality of life.
- Being tested
- Lower-limb drainage isotopic intraoperative detection
- Keywords
- gynaecological malignancy, pelvic lymphadenectomy, lymphedema, sentinel node, reverse mapping
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-limb drainage isotopic intraoperative detectionProcedure or surgery
A radiopharmaceutical is injected into both feet on the day before surgery. Pelvic lower-limb drainage nodes (LLDNs) are identified using preoperative SPECT-CT and intraoperative isotopic probe detection, and then electively removed before complete pelvic lymphadenectomy. LLDNs and pelvic lymphadenectomy specimens undergo separate histological analysis.
| Study group | Role | What they receive |
|---|---|---|
| isotopic intraoperative detection | Experimental | Lower-limb drainage isotopic intraoperative detection Receives: Procedure: Lower-limb drainage isotopic intraoperative detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
Measured: day of surgery
Secondary outcomes (3)
Anatomy of lower-limb drainage
Measured: day of surgery
Percentage of patients with metastatic lower limb sampling
Measured: 2 weeks after surgery
Follow-up of patients to identify complications, and namely lower-limb lymphedema.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJul 2013
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological Malignant Tumours With Indication of Pelvic LymphadenectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie BATS, MD, PhD, Principal investigator, assistance publique des hopitaux de paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946672
- Sponsor's protocol ID
- P110903
- Acronym
- SENTIJAMBE
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2013
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
- ClinicalTrials.gov ID
- NCT01946672
- Acronym / sponsor ID
- SENTIJAMBE / P110903
- Keywords
- gynaecological malignancy, pelvic lymphadenectomy, lymphedema, sentinel node, reverse mapping
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.
Detailed description
Pelvic lymphadenectomy is associated with a significant risk of lower-limb lymphedema. In this study, we evaluate the feasibility of identifying the lower-limb drainage nodes (LLDNs) during pelvic lymphadenectomy for gynaecological cancers using an isotopic detection technique with a preoperative radiopharmaceutical injection into both feet Secondary objectives are to map lower-limb drainage, to assess the diagnostic value of our mapping technique, and to determine the incidence of lymphedema. LLDN mapping may allow the preservation of LLDNs, thereby decreasing the risk of lower-limb lymphedema and improving quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isotopic intraoperative detection | Experimental | Procedure: Lower-limb drainage isotopic intraoperative detectionLower-limb drainage isotopic intraoperative detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:
- Must provide her signed and informed consent
- Beneficiary of a health insurance
- Having received a medical examination
Key exclusion criteria (6 listed)
- Contraindication to pelvic lymphadenectomy
- Presence of lymphedema of the lower limbs
- Contraindication to radiomarkers (allergy or hypersensitivity to any component of the biomarker)
- Patient with dementia or altered mental status
- Pregnant or breast feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower-limb drainage isotopic intraoperative detectionA radiopharmaceutical is injected into both feet on the day before surgery. Pelvic lower-limb drainage nodes (LLDNs) are identified using preoperative SPECT-CT and intraoperative isotopic probe detection, and then electively removed before complete pelvic lymphadenectomy. LLDNs and pelvic lymphadenectomy specimens undergo separate histological analysis. | Procedure or surgery | isotopic intraoperative detection |
Primary outcome
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
Time frame: day of surgery
3 secondary outcomes
Anatomy of lower-limb drainage
Time frame: day of surgery
Percentage of patients with metastatic lower limb sampling
Time frame: 2 weeks after surgery
Follow-up of patients to identify complications, and namely lower-limb lymphedema.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie BATS, MD, PhD principal investigator
assistance publique des hopitaux de paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lower-limb drainage isotopic intraoperative detection in people with Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. (time frame: day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.